Best FDA US Agent Services | Compare & Get Quotes

Q: What does an FDA U.S. Agent do?

An FDA U.S. Agent (also called FDA US agent or U.S. agent FDA ) is a person or entity located in the United States who serves as the official point of contact for the FDA regarding a foreign establishment's medical device registration and listing under 21 CFR Part 807 [1] . The U.S. Agent acts as a communications intermediary between the foreign manufacturer and the FDA [1] . Key responsibilities include: receiving communications from FDA on behalf of the foreign establishment [1] , forwarding FDA communications to the foreign manufacturer in a timely manner [1] , responding to FDA requests for information or documentation [1] , facilitating FDA inspections if required [1] , and supporting administrative tasks related to FDA registration and listing [1] . The FDA US agent must be physically located in the U.S. [1] and available during normal business hours [1] (though some FDA US agent services providers offer 24/7 availability). The agent does not assume liability for the device but serves as a critical communication link.

Q: Is a U.S. Agent required for all foreign manufacturers?

Yes, FDA regulations (21 CFR Part 807 [1] ) require all foreign establishments (manufacturers, specification developers, contract manufacturers, contract sterilizers, repackagers, relabelers, and initial distributors/importers) to designate a U.S. Agent (also called FDA US agent or U.S. agent FDA ) when registering with the FDA [1] . This requirement applies regardless of device class or whether the device requires premarket approval [1] . The U.S. Agent must be designated at the time of initial registration [1] and must be maintained as long as the establishment remains registered [1] . If you're a foreign manufacturer placing medical devices on the U.S. market, you must have a FDA US agent —there are no exceptions to this requirement under current FDA regulations [1] .

Q: What should I check before choosing a U.S. Agent?

When selecting a FDA U.S. Agent (also called FDA US agent or U.S. agent FDA ), evaluate: reliability and track record (how long they've been in business, client references), responsiveness (SLA for forwarding FDA communications [1] , availability during business hours [1] or 24/7), FDA experience (understanding of FDA processes, relationships with FDA, knowledge of medical device regulations [1] ), change control and notification terms (how they handle changes to your registration [1] , device listings, etc.), technology and communication (online portal for tracking communications, secure document transfer), additional services (if you need registration support [1] , inspection assistance [1] , etc.), and pricing transparency (clear fee structure, no hidden costs). Also verify they're physically located in the U.S. [1] and can provide a U.S. address and phone number for FDA records [1] .

Q: What happens if my U.S. Agent doesn't forward FDA communications promptly?

Timely communication is critical for FDA compliance [1] . If your FDA U.S. Agent (also called FDA US agent ) fails to forward FDA communications promptly [1] , you may miss important deadlines, requests for information, or inspection notifications [1] , which can result in: delayed device approvals, FDA enforcement actions, registration issues [1] , and potential market access problems. FDA expects foreign manufacturers to respond to communications within specified timeframes [1] , and delays can impact your ability to maintain compliance. When selecting a U.S. agent FDA , verify their SLA for forwarding communications (many FDA US agent services providers commit to same-day or 24-hour forwarding) and their process for urgent communications. Some FDA agent providers offer 24/7 availability and expedited handling for critical FDA communications. If your current agent is not responsive, you can change agents [1] , though this requires updating your FDA registration [1] .

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Compare Best FDA US Agent Services | Compare & Get Quotes Providers

For the most complete service details (including category-specific capabilities and requirements), open any provider profile below. Each profile contains full coverage, service details, and a direct quote request flow.

Registrar Corp

Registrar Corp is a leading provider of FDA agent services, ensuring compliance for businesses operating in the United States.

Registrar Corp specializes in providing essential services for companies needing to comply with U.S. Food and Drug Administration (FDA) regulations. As a dedicated FDA agent, they act as a crucial liaison between foreign and domestic businesses and the FDA, facilitating communication and ensuring all regulatory requirements are met. Their expertise covers a wide range of FDA-related needs, including registration and listing, product submissions, and regulatory consulting. By leveraging Registrar Corp's services, businesses can navigate the complex landscape of FDA compliance with confidence, minimizing risks and accelerating market entry. They are committed to offering efficient and reliable solutions tailored to the specific needs of each client, making them a trusted partner in the pharmaceutical, medical device, and food industries.

Website: registrarcorp.com

HQ: Hampton, US

Jurisdictions: US

Countries: US

Languages: English, Spanish

Response SLA: 24 hours

Onboarding time: 1–3 days

Pricing model: Retainer

Starting from: USD 1,500

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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NSF (FDA US Agent Services)

NSF is a global leader in public health and safety, offering certification and standards development for products and systems. They ensure compliance with rigorous hygiene and safety protocols.

NSF is a renowned organization dedicated to protecting and improving public health and safety worldwide. They achieve this through rigorous testing, certification, and the development of standards across various industries. NSF's expertise extends to ensuring products and systems meet stringent EU minimum hygiene standards, as evidenced by their commitment to published standards and protocols. For businesses seeking to demonstrate compliance and build consumer trust, NSF provides a comprehensive suite of services. Their certification process is independent, meaning that the use of NSF consulting services or training does not influence the granting of certification. This ensures the integrity and credibility of the NSF mark. As a trusted authority, NSF plays a crucial role in the supply chain, offering assurance to consumers and regulators alike. Their work supports the availability of safe products and promotes a healthier global community.

Website: nsf.org

HQ: Ann Arbor, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 1–3 days

Pricing model: Retainer

Starting from: USD 1,500

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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EAS Consulting Group

EAS Consulting Group specializes in FDA regulatory matters, offering expert guidance and compliance solutions for industries regulated by the FDA, USDA, and supporting agencies. They provide services like consulting, submissions, auditing, and training.

EAS Consulting Group is a premier provider of regulatory compliance solutions for companies operating under FDA, USDA, and related agencies. Their team of seasoned consultants offers expert guidance across a spectrum of regulatory requirements, including consulting, submissions, auditing, and training. They are particularly adept at assisting foreign firms importing FDA-regulated products into the United States, acting as a crucial intermediary to navigate import challenges, ensure compliance, and facilitate timely market entry. This includes services such as submissions assistance, facility registrations, and handling detained products. Furthermore, EAS Consulting Group prepares foreign firms for FDA foreign inspections through "Mock-FDA" inspections and assists those found in violation to implement necessary corrections. They also offer specialized support for issues like FDA Form 483 responses, 21 CFR Part 11 compliance for electronic records, and recall assistance, aiming to prevent escalated enforcement actions and ensure adherence to the highest regulatory standards.

Website: easconsultinggroup.com

HQ: Alexandria, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 1–3 days

Pricing model: Onboarding + annual retainer

Starting from: USD 950

FDA Services: Registration Support

Features: Inspection Support

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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AlvaMed (FDA US Agent Representation)

AlvaMed provides comprehensive regulatory consulting for the medical device industry, specializing in FDA US Agent Representation, 510(k) submissions, and quality system development.

AlvaMed is a dedicated consulting firm serving the medical device industry, offering a wide array of compliance services tailored for both large and small medtech companies. Their expertise encompasses quality assurance, quality system development, regulatory affairs, and clinical affairs. Specializing in FDA US Agent Representation, AlvaMed assists clients with critical regulatory processes such as FDA 510(k) submissions, IDE submissions, and establishment registration and device listing. They provide comprehensive support to ensure efficient navigation of regulatory pathways and compliance requirements. Beyond regulatory submissions, AlvaMed offers robust solutions for quality management systems, including QMS setup, administration, remediation, and harmonization. Their services also extend to CAPA program management, auditing, and risk management file remediation, ensuring adherence to industry standards and regulations.

Website: alvamed.com

HQ: Irvine, US

Jurisdictions: US

Countries: US

Languages: English, Spanish

Response SLA: 24 hours

Onboarding time: 1–3 days

Pricing model: Onboarding + annual retainer

Starting from: USD 950

FDA Services: Registration Support

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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FDA Solutions Group, LLC

FDA Solutions Group, LLC is a regulatory compliance company specializing in FDA registration and listing services for food, beverages, dietary supplements, medical devices, and cosmetics. They offer streamlined, cost-effective solutions to complex regulatory requirements.

FDA Solutions Group, LLC is a specialized regulatory compliance company dedicated to assisting businesses with U.S. Food and Drug Administration (FDA) registration and compliance requirements. They focus on industries including food, beverages, dietary supplements, alcoholic beverages, medical devices, and cosmetic products. Their team of regulatory compliance specialists possesses decades of FDA industry and regulatory experience, ensuring high-quality service and client satisfaction. FDA Solutions Group, LLC offers simplified and cost-effective solutions to complex regulatory requirements, providing fixed fees without hidden costs. They have developed a streamlined approach allowing clients to submit registration and listing information directly through their website at any time, from anywhere in the world.

Website: fdasolutionsgroup.com

HQ: Miami, United States

Jurisdictions: US

Countries: US

Languages: English, Spanish

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 600

FDA Services: Registration Support

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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Willow Glen Consultancy LLC

Willow Glen Consultancy LLC offers FDA registration and U.S. Agent services for international and domestic food facilities and medical device establishments. They provide transparent pricing and a 30-day money-back guarantee.

Willow Glen Consultancy LLC specializes in providing essential FDA services for businesses operating in the United States. They offer comprehensive FDA registration and U.S. Agent services tailored for both international and domestic food facilities, as well as medical device establishments. Their services include registration or modification, a one-year U.S. agent communication service, free electronic certificates, and complimentary modifications or renewals during the service period. Known for their transparent pricing, Willow Glen Consultancy LLC ensures there are no hidden charges. They are committed to customer satisfaction and offer a risk-free, 30-day money-back guarantee for new customers. Located in San Diego, USA, they are a trusted partner for navigating complex FDA regulations.

Website: willowglenfda.com

HQ: San Diego, USA

Jurisdictions: US

Countries: US

Languages: English, Chinese

Response SLA: 48 hours

Onboarding time: 1–10 days

Pricing model: Custom pricing

Starting from: USD 299

FDA Services: Registration Support

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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MarketReady Insights

MarketReady Insights offers expert regulatory guidance and consulting services for CPG brands and ingredient suppliers. They make regulatory compliance easy and accessible, helping businesses navigate complex requirements for market entry and growth.

MarketReady Insights, part of the Informa Markets Division of Informa PLC, specializes in making regulatory compliance easy and accessible for CPG brands and ingredient suppliers. They provide expert guidance through affordable consulting packages and services, ensuring businesses can start and remain compliant as they grow. Whether you're selling on Amazon, nationwide, or locally, MarketReady Insights understands that retailers prioritize "market ready" brands. Products that don't comply with regulations expose retailers to risk, damage their image, and create operational hassles. MarketReady Insights acts as your personalized guide, leveraging Informa's extensive Health & Nutrition portfolio to provide the intelligence, connections, and opportunities needed to make informed decisions and achieve business objectives. Their services include Labeling Review, Marketing & Claims Review, Website Review, Nutrition Facts Panel Creation, Consulting, and FDA Food Facility Registration, including U.S. Agent Services. They are dedicated to elevating the integrity of the products and businesses within the markets they serve, empowering businesses to turn ideas into successful realities.

Website: marketreadyinsights.com

HQ: London, UK

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 1–10 days

Pricing model: Custom pricing

Starting from: USD 299

FDA Services: Registration Support

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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FDAAgentPro Pro

FDAAgentPro provides expert U.S. FDA Agent, Registration, Export Certificate, and FSVP Agent services for foreign and domestic companies. Ensure compliance with FDA regulations for food, drugs, cosmetics, and medical devices.

FDAAgentPro specializes in comprehensive FDA compliance solutions for businesses worldwide. We offer professional U.S. Agent representation, ensuring seamless communication and adherence to FDA requirements for foreign facilities. Our services include FDA Registration for food, drug, cosmetic, and medical device facilities, including MoCRA Act compliance. We also provide FDA Export Certificate services tailored to specific industries and product categories, facilitating international trade. For food importers, our FSVP Agent services ensure compliance with U.S. food safety standards by managing supplier verification, record-keeping, and communication with the FDA. FDAAgentPro is your trusted partner for navigating complex FDA regulations and maintaining operational integrity.

Website: fdaagentpro.com

HQ: Miami, US

Jurisdictions: US

Countries: US

Languages: English, Spanish

Response SLA: 48 hours

Onboarding time: 1–10 days

Pricing model: Custom pricing

Starting from: USD 299

FDA Services: Registration Support

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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DSI (US Agent Services)

Regulatory consulting firm providing FDA U.S. Agent services for foreign establishments, including registration, listing, communication with FDA, and inspection / compliance support.

DSI (DS InPharmatics) provides FDA U.S. Agent services for international pharmaceutical companies and other FDA-regulated products. They act as the required point of contact between foreign establishments and the FDA, handling establishment registration, product listing, regulatory communications, inspection coordination, and compliance support. DSI serves as your trusted U.S. Agent, ensuring adherence to all relevant FDA regulations and serving as a dependable liaison between your organization and the FDA.

Website: dsinpharmatics.com

HQ: Mesa, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 1–3 days

Pricing model: Onboarding + annual retainer

Starting from: USD 950

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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mdi Consultants

mdi Consultants offers expert FDA regulatory compliance services, specializing in U.S. Agent representation for foreign medical device, pharmaceutical, and food manufacturers. They ensure seamless communication and compliance with FDA regulations.

mdi Consultants, Inc. is a leading provider of FDA regulatory compliance consulting with over 45 years of experience. They specialize in assisting medical device, pharmaceutical, and food industry companies worldwide in achieving regulatory and standards compliance. Their services are crucial for foreign-based manufacturers who need a U.S. Agent to register their facilities, list products, and submit FDA marketing authorization applications without establishing a physical presence in the United States. As an experienced U.S. Agent to the FDA, mdi Consultants acts as an effective liaison between your company and the FDA. They manage all communications, including scheduling FDA inspections, handling import detention issues, and addressing compliance questions. Their expertise also extends to FDA legal counsel and risk management, particularly for businesses operating in federally regulated environments. mdi Consultants stays up-to-date with the latest FDA regulations and user fees, providing timely information and tailored consulting services. They are dedicated to helping international clients navigate the complexities of the U.S. market and maintain compliance with FDA requirements.

Website: mdiconsultants.com

HQ: New York, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 600

FDA Services: Registration Support

Features: Inspection Support

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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Liberty Management Group (FDA Registration & US Agent)

Liberty Management Group Ltd is a globally recognized FDA, CE Marking, and ISO consulting firm headquartered in Illinois, USA. They specialize in FDA registration, US FDA agent services, and regulatory compliance for various product types.

Liberty Management Group Ltd (LMG) is a globally recognized consulting firm specializing in FDA regulations, CE Marking, and ISO standards. Headquartered in Aurora, Illinois, USA, LMG offers a comprehensive suite of services to both domestic and foreign establishments. Their expertise includes FDA registration for food, drugs, APIs, medical devices, and cosmetics, as well as acting as a US FDA Agent for foreign establishments. LMG also provides services related to NDC Labeler Code requests, Drug Master Files, Drug Establishment Registration and Renewal, Premarket Notification (510k), Establishment Registration and Listing, Medical Device Labeling, and UDI submission. LMG is committed to helping clients navigate complex regulatory requirements, ensuring compliance with FDA mandates such as drug reporting, cosmetic facility registration and listing under MoCRA, and unique device identification (UDI) systems. They offer competitive fees and transparent pricing, assisting businesses in successfully bringing their products to the US market.

Website: fdahelp.us

HQ: Aurora, USA

Jurisdictions: US

Countries: US

Languages: English, Spanish

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 600

FDA Services: Registration Support

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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Compliance Insight, Inc.

Regulatory consulting firm specializing in FDA compliance for life sciences: services include U.S. Agent, registration & listing, audits, GMP/GCP, warning letter mitigation, quality systems, and regulatory submission support.

Compliance Insight, Inc. is a life sciences regulatory consulting firm helping companies in pharmaceuticals, biologics, and medical devices with FDA regulatory compliance. They offer FDA U.S. Agent and Official Correspondent services to assist foreign establishments with the FDA Unified Registration and Listing System (FURLS). They serve as the primary point of contact for the FDA regarding establishment registration and product listing. Additional services include regulatory submissions, audits, gap assessments, training, warning letter responses, GMP, GCP, and quality systems support.

Website: complianceinsight.ca

HQ: Kitchener, Canada

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 600

FDA Services: Registration Support

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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Ken Block Consulting (US Agent / Official Correspondent)

Medical device regulatory consulting firm offering FDA US Agent services for foreign companies, establishment registration, device listings, compliance strategy, quality systems and regulatory submissions.

Ken Block Consulting (KBC) specializes in FDA regulatory and consulting services for medical device companies. They offer US Agent and Official Correspondent services for foreign medical device establishments, facilitating communication between the FDA and foreign entities. Services include FDA registration and listing, 510(k)/PMA/De Novo submissions, quality systems design, validation, inspection readiness, and regulatory strategy. KBC assists with addressing inquiries regarding devices imported into the United States and helps schedule FDA inspections.

Website: kenblockconsulting.com

HQ: Richardson, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 1–10 days

Pricing model: Custom pricing

Starting from: USD 299

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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QA/RA Consulting Group, Inc.

QA/RA Consulting Group, Inc. offers expert regulatory affairs, quality management, and product development services for medical devices, IVDs, and combination devices. They specialize in FDA US Agent and Official Correspondent services for international clients.

Founded in 2012 and based in Pittsburgh, Pennsylvania, QA/RA Consulting Group, Inc. (QA/RA CG) is a leader in providing comprehensive quality, regulatory, and compliance services for medical devices, IVDs, and combination devices. They assist clients globally, from startups to Fortune 500 companies, in achieving ambitious commercialization goals while ensuring necessary compliance levels. Their expertise spans the entire product lifecycle, including design, development, manufacturing, marketing, and distribution. QA/RA CG offers specialized services such as Regulatory Affairs, Quality Management Systems, Auditing, QA/RA Outsourcing, Design and Development, and U.S. Agent/Initial Importer Services. They are particularly adept at navigating global regulatory requirements and have prior direct interaction with regulators. For international clients, QA/RA Consulting Group provides crucial FDA U.S. Agent and Official Correspondent services, acting as the initial point of contact with the FDA. They handle communications, respond to FDA inquiries, and ensure foreign manufacturers meet registration requirements. Their approach is characterized by clear, effective, and frequent communication, direct leadership involvement, and a commitment to building strong partnerships based on trust and integrity.

Website: qaraconsultinggroup.com

HQ: Pittsburgh, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 600

FDA Services: Registration Support

Features: 24/7 Emergency

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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FDA Specialist

FDASpecialist provides comprehensive FDA regulatory compliance services for foods, dietary supplements, cosmetics, medical devices, and drugs. Services include facility registration, US Agent services, product listings, label reviews, FSVP compliance, import hold/detention resolution, and import alert petitioning. Led by Richard Chiang, Owner and Chief Consultant.

FDA Specialist offers comprehensive services to navigate the complex landscape of FDA regulations. With extensive experience, including a former FDA specialist with 13 years of service, they provide expert guidance on food facility registration, medical device requirements, cosmetic regulations under MoCRA, and the FDA drug approval process. They are particularly adept at assisting foreign facilities by acting as a US agent, facilitating communication with the FDA, and helping to schedule inspections. Their services extend to ensuring compliance with various import regulations, including Foreign Supplier Verification Program (FSVP) for food, and Prior Notice submissions. For medical devices, they clarify regulatory classifications and assist with establishment registration and premarket notifications. For cosmetics, they address facility registration and product listing requirements. For drugs, they guide through establishment registration, drug listing, and adherence to Good Manufacturing Practices (GMPs). FDA Specialist is committed to helping businesses understand and meet FDA requirements, ensuring smooth market entry and ongoing compliance. They offer free consultations to discuss specific needs and provide tailored solutions for businesses dealing with FDA-regulated products.

Website: fdaspecialist.com

HQ: Long Beach, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 1–10 days

Pricing model: Custom pricing

Starting from: USD 299

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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Food Consultations (FDA Registration & US Agent)

Provides FDA registration and US Agent services for food facilities, including compliance with Bioterrorism Act requirements. Specializes in navigating FDA Industry Systems for submissions and notifications.

Food Consultations offers specialized services for FDA registration and acts as a US Agent for food facilities. They facilitate compliance with critical regulations, including those mandated by the Bioterrorism Act of 2002, ensuring that facilities manufacturing, processing, packing, or holding food products for the U.S. market are properly registered. Their expertise extends to utilizing the FDA Industry Systems (FIS), a 24/7 platform designed for making submissions to the U.S. Food and Drug Administration. This includes managing registrations, listings, and other necessary notifications. The system was developed to enhance information management for food supply protection. Services cover various FDA-related forms and systems, such as FURLS Acidified/Low Acid Canned Foods (LACF), Biologics Export Certification Application & Tracking System (BECATS), Export Listing Module (ELM), and systems for Drug, Medical Device, and Human Cell/Tissue establishments. They assist with forms like 2541/2541d/2541e/2541f/2541g and provide guidance on associated OMB approval numbers and expiration dates.

Website: foodconsultations.com

HQ: Seattle, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 1–10 days

Pricing model: Custom pricing

Starting from: USD 299

FDA Services: Registration Support

Features: 24/7 Emergency

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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FDABasics

FDABasics provides essential resources and guidance for navigating FDA regulations, helping businesses ensure compliance and market access.

FDABasics is dedicated to simplifying the complex landscape of FDA regulations for businesses. They offer comprehensive information and tools to assist with compliance, product registration, and understanding regulatory requirements. Their platform serves as a valuable resource for companies seeking to bring products to market safely and efficiently, ensuring adherence to all necessary FDA guidelines. As a provider within the us_agent_fda directory, FDABasics focuses on delivering clear, actionable insights into FDA processes. Whether you are a startup or an established enterprise, FDABasics aims to be your trusted partner in managing FDA-related challenges and opportunities.

Website: fdabasics.com

HQ: Orlando, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 1–10 days

Pricing model: Custom pricing

Starting from: USD 299

FDA Services: Registration Support

Features: Inspection Support

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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Magneco LLC

Magneco LLC offers comprehensive FDA regulatory consulting and support for food and beverage exporters. They specialize in FDA registration, U.S. Agent services, FSVP compliance, and labeling.

Magneco LLC is a dedicated provider of regulatory consulting and support for industries regulated by the FDA, USDA, and other federal and state agencies. They assist food exporters worldwide in meeting tailored solutions to comply with FDA regulations. Their core services include FDA Registration, FCE-SID Registration, acting as the FDA U.S. Agent, DUNS – UFI Number acquisition, FDA FSVP (Foreign Suppliers Verification Programs), Food Safety Plan development, FSVP Agent services, FDA Labeling compliance, and Recall Plan creation. Magneco LLC focuses on providing solid solutions for food and beverage imports/exports, creating unique plans based on client needs. Their team of food scientists is ready to help ensure your products meet all necessary U.S. safety and labeling standards, facilitating smooth entry into the U.S. market.

Website: magneco.us

HQ: Houston, US

Jurisdictions: US

Countries: US

Languages: English, Spanish

Response SLA: 48 hours

Onboarding time: 1–10 days

Pricing model: Custom pricing

Starting from: USD 299

FDA Services: Registration Support

Features: 24/7 Emergency

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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ITB Holdings LLC

ITB Holdings LLC is a U.S. Agent and FDA compliance service provider, assisting foreign companies with FDA registration, U.S. Agent designation, and navigating complex U.S. FDA regulations for various products.

ITB Holdings LLC specializes in facilitating FDA registration and compliance for foreign companies looking to export to the United States. As an authorized U.S. Agent, they act as the primary point of contact between foreign facilities and the U.S. Food and Drug Administration, ensuring smooth communication and adherence to regulatory requirements. Their services cover a wide range of products, including Foods, Dietary Supplements, Alcoholic Beverages, Medical Devices, Drugs (Prescription and OTC), Cosmetics, and more. ITB Holdings LLC assists with crucial processes such as FDA registration, U.S. Agent designation, Prior Notice, Foreign Supplier Verification Program (FSVP), and FDA labeling compliance. With a commitment to simplifying the export process, ITB Holdings LLC helps companies expand their market reach by ensuring their facilities are registered and compliant with U.S. FDA standards. They offer expert guidance on regulatory nuances, helping clients avoid common pitfalls and maintain a strong compliance posture in the U.S. market.

Website: itbholdingsllc.com

HQ: Orlando, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 1–10 days

Pricing model: Custom pricing

Starting from: USD 299

FDA Services: Registration Support

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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MDSS

MDSS provides expert In-Country Representation and regulatory affairs services for medical and IVD devices, specializing in EU Authorized Representation and FDA U.S. Agent services.

MDSS is a seasoned provider of In-Country Representation and regulatory affairs services, boasting over 30 years of experience assisting medical and in vitro diagnostic device manufacturers. They specialize in navigating complex regulatory landscapes, offering services such as EU Authorized Representation, UK Responsible Person, Swiss Authorized Representative, and U.S. Agent services. For non-EU manufacturers, MDSS acts as a crucial liaison with regulatory bodies like the FDA, ensuring seamless market access and compliance with U.S. FDA regulations. They also provide expert guidance on evolving regulations such as the AI Act and QMSR, helping clients meet all mandatory requirements and minimize risks. MDSS is committed to simplifying the regulatory journey for their clients, allowing them to focus on innovation and core business operations.

Website: mdss.com

HQ: Schleswig, DE

Jurisdictions: US

Countries: US

Languages: English, German

Response SLA: 24 hours

Onboarding time: 1–5 days

Pricing model: Retainer

Starting from: USD 2,000

Included Services: FDA communications handling, Establishment registration support, Device listing assistance, Inspection coordination

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MedEnvoy Global

MedEnvoy Global is a leading regulatory consulting firm specializing in medical device market entry and compliance in the US and globally. They offer expert guidance for FDA submissions, registration, and QMS.

MedEnvoy Global is your premier partner for navigating the complexities of medical device and IVD global market entry. Specializing in US FDA compliance, they offer comprehensive services including US FDA Agent representation, FDA Establishment and Medical Device Registration Support, FDA 510(k) clearance consulting, FDA Premarket Approval (PMA) submission consulting, FDA 513(g) classification requests, and FDA Q-Sub/Pre-Sub program guidance. With over 25 years of experience, MedEnvoy Global's executive management has served as FDA registered medical device US agents for over 500 overseas companies. Their Austin, Texas-based office ensures seamless communication with both your company and the FDA. They streamline compliance in your distribution chain, helping you meet specific country regulations and enter new markets seamlessly. MedEnvoy Global provides end-to-end support, from initial strategy development to final submission. Their team of experts helps identify regulatory pathways, develop robust plans, compile necessary documentation, and ensure your submissions meet the highest standards of clarity, completeness, and compliance. They are dedicated to removing barriers and providing clarity for your global regulatory needs.

Website: medenvoyglobal.com

HQ: Austin, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 1,800

FDA Services: Registration Support

Included Services: FDA communications handling, Establishment registration support, Device listing assistance, Inspection coordination

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US FDA Agents

US FDA Agents provides specialized services for navigating FDA regulations and compliance. They assist businesses in meeting federal requirements for food, drugs, and medical devices.

US FDA Agents is a dedicated service focused on assisting clients with the complex landscape of U.S. Food and Drug Administration (FDA) regulations. Their expertise lies in guiding businesses through the intricacies of compliance, ensuring adherence to federal standards for a wide range of products including food, pharmaceuticals, medical devices, and cosmetics. Leveraging deep knowledge of FDA policies and procedures, US FDA Agents offers comprehensive support to help companies achieve and maintain regulatory approval and market access. They are committed to providing clear, actionable guidance to streamline the often-challenging process of FDA compliance, thereby enabling clients to bring safe and effective products to the American market with confidence.

Website: usfdaagents.com

HQ: New York, US

Jurisdictions: US

Countries: US

Languages: English, Spanish, French, German, Italian, Portuguese, Dutch, Filipino

Response SLA: 48 hours

Onboarding time: 1–3 days

Pricing model: Retainer

Starting from: USD 800

Included Services: FDA communications handling, Registration support, Basic compliance assistance

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Catain Labs

Catain Labs offers comprehensive FDA regulatory consulting, eCTD publishing, and US Agent services for pharmaceutical and biotech companies. They simplify compliance and accelerate approvals.

Catain Labs specializes in guiding pharmaceutical, biotechnology, and healthcare companies through the complex U.S. regulatory landscape, making FDA compliance straightforward, reliable, and efficient. With expertise in IND, NDA, ANDA, NDC, FEI, GDUFA, and eCTD submissions, they provide end-to-end regulatory support tailored to business needs. For foreign companies, Catain Labs serves as the official U.S. Agent, seamlessly handling FDA communication, submissions, and compliance requirements. They also manage the entire registration and annual renewal process for manufacturing, repacking, or distribution facilities, and provide complete support for applying for, assigning, and maintaining National Drug Code (NDC) numbers. Their services include preparing, formatting, validating, and submitting applications in eCTD format to ensure smooth FDA review. Catain Labs acts as a regulatory partner, helping clients minimize risks, reduce delays, and achieve approvals with confidence.

Website: catainlabs.com

HQ: New Jersey, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–5 days

Pricing model: Retainer

Starting from: USD 1,500

FDA Services: Registration Support

Included Services: FDA communications handling, Establishment registration support, Product listing assistance, Inspection coordination

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BLA Regulatory

BLA Regulatory offers expert FDA regulatory consulting and U.S. Agent representation for drug and medical device companies. They facilitate IND filings, clinical trial strategy, and navigate complex regulatory pathways.

BLA Regulatory is a specialized consulting firm providing comprehensive regulatory services for drug and medical device companies seeking to enter or operate within the U.S. market. With extensive experience in IND filings, clinical trial registration, and strategy development, they act as a crucial U.S. Agent, facilitating interaction with the FDA on behalf of foreign sponsors. Their expertise spans the entire product lifecycle, from initial research and nonclinical development through submission, approval, and post-market maintenance. BLA Regulatory excels in formalizing meetings with regulatory agencies, providing critical regulatory insight, and ensuring operational efficiency. They offer tailored end-to-end approaches, translating complex regulatory requirements into actionable plans to expedite product development and market entry. BLA Regulatory's services are designed to support companies, particularly startups and small biotechs, in navigating the intricacies of FDA compliance. They offer guidance on medical device classification through 513(g) requests, develop robust IND/CTA strategies with NDA/BLA submissions in mind, and provide essential support for clinical trial recruitment and registration. Their team of FDA-experienced experts, industry leaders, and regulatory professionals ensures clients receive competent and reliable support to achieve their development and commercialization goals.

Website: bla-regulatory.com

HQ: Gaithersburg, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 1,700

Included Services: FDA communications handling, Establishment registration support, Product listing assistance, Regulatory submission support

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Emergo by UL

Emergo by UL offers comprehensive regulatory consulting and human factors expertise for medical device and IVD companies seeking global market access. They provide services for compliance, registration, privacy, and security.

Emergo by UL is a specialized provider of regulatory consulting services for the medical device and In Vitro Diagnostic (IVD) industries. They assist companies in navigating complex global market access requirements, ensuring compliance with various regulatory bodies. Their expertise spans critical areas such as medical device registration, human factors research and design, privacy and security consulting (including HIPAA and GDPR), and post-market surveillance. Leveraging a deep understanding of the evolving healthcare landscape, Emergo by UL offers a platform of digital products and tools designed to simplify and automate Regulatory Affairs/Quality Assurance (RA/QA) activities. This includes solutions for regulatory monitoring, human factors engineering, and compliance tracking. They also provide in-country representation and support for obtaining necessary certifications like Certificates of Free Sale. With a focus on enabling innovation and simplifying compliance, Emergo by UL empowers manufacturers to bring their products to market efficiently and securely. Their services are tailored to address the specific needs of device manufacturers, from initial product classification and development through to ongoing market surveillance and regulatory intelligence.

Website: emergobyul.com

HQ: Austin, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 2,200

FDA Services: Registration Support

Included Services: FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders

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Obelis Group

Obelis Group is your trusted partner for global regulatory compliance, specializing in market access for Medical Devices, Cosmetics, Food Supplements, Toys, Motor Vehicles, and other industries across the EU, UK, US, and Switzerland.

Obelis Group provides comprehensive regulatory compliance services to facilitate market access for a wide range of products, including Medical Devices, Cosmetics, Food Supplements, Toys, Motor Vehicles, and other industries. They specialize in navigating complex regulations across the EU, UK, US, and Switzerland, acting as your Authorised Representative and Responsible Person. Their services encompass product registration, documentation review, labeling compliance, safety assessments, and liaison with regulatory authorities. Obelis Group ensures your products meet all legal requirements, from initial market entry to ongoing compliance, helping you avoid risks and accelerate your business growth. With extensive experience, Obelis Group offers tailored solutions including regulatory training, GPSR compliance, and CE marking guidance. They are dedicated to protecting your brand reputation and ensuring consumer safety by keeping your products compliant with the latest legislation. Whether you are establishing a presence in the EU or expanding your reach globally, Obelis Group provides the expertise and support needed for seamless and secure market access.

Website: obelisgroup.com

HQ: Brussels, BE

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 1,900

FDA Services: Registration Support

Features: Inspection Support

Included Services: FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders

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Global Regulatory Partners

Global Regulatory Partners (GRP) offers end-to-end regulatory affairs and compliance services for pharmaceuticals, medical devices, cosmetics, nutraceuticals, and food supplements. They provide global reach with local expertise, acting as authorized local agents in various countries.

Global Regulatory Partners, Inc. (GRP) provides comprehensive regulatory affairs and compliance services across the entire product lifecycle, serving industries such as Pharmaceuticals, Medical Devices, Cosmetics, Nutraceuticals, and Food Supplements. With a "Global Reach, Local Presence and Expertise" approach, GRP has local offices in the USA, Asia, Latin America, and Europe, enabling them to offer localized support. GRP specializes in assisting companies with navigating complex regulatory environments. They offer services including Regulatory Intelligence, strategy development, and acting as an Authorized Local Agent in key markets like the United States (FDA), Canada (Health Canada), Mexico (COFEPRIS), and Europe (EMA). Their expertise is particularly valuable for medical device companies seeking to register and commercialize products in new markets. The company emphasizes developing tailored regulatory strategies to meet specific business objectives, minimize risk, and ensure efficient product development, registration, and commercialization. GRP's team provides insights into necessary documentation, timelines, costs, and action plans to help clients achieve their milestones.

Website: globalregulatorypartners.com

HQ: Boston, USA

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 1,800

FDA Services: Registration Support

Included Services: FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders

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Regulatory Compliance Associates

Regulatory Compliance Associates (RCA) is a leading life science consulting firm specializing in regulatory affairs and compliance for pharmaceutical and medical device companies. They offer expert guidance through product development, clearance, and post-approval stages.

Regulatory Compliance Associates (RCA), a Nelson Labs company and part of the Sotera Health group, provides comprehensive regulatory consulting services for the pharmaceutical and medical device industries. With extensive experience, RCA assists clients in navigating complex regulatory landscapes, including product development, FDA submissions like 510(k), and post-approval support. Their expertise covers a wide range of services such as U.S. Agent representation, FDA 483 and CAPA management, and ensuring compliance with evolving regulations like the EU Medical Device Regulation (MDR). RCA is dedicated to helping thousands of global clients meet their regulatory, compliance, and quality assurance challenges. Headquartered in Wisconsin, RCA is a trusted partner to many leading companies, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies. They are committed to providing high-performing consulting careers in life science compliance and regulation.

Website: rcainc.com

HQ: Wisconsin, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 2,000

FDA Services: Registration Support

Features: Inspection Support

Included Services: FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders

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Greenleaf Health

Greenleaf Health is a premier FDA consulting firm specializing in assisting companies with FDA registration and compliance. They offer expert guidance for navigating complex regulatory requirements.

Greenleaf Health is a dedicated FDA consulting firm committed to simplifying the process of FDA registration and compliance for businesses worldwide. They leverage their extensive expertise to guide clients through the intricacies of FDA regulations, ensuring adherence and facilitating market entry. Their services are tailored to meet the specific needs of companies seeking to operate within the United States market, particularly those requiring FDA approval or registration. Greenleaf Health focuses on providing clear, actionable advice and comprehensive support throughout the entire regulatory journey. With a deep understanding of FDA requirements, Greenleaf Health acts as a crucial partner for businesses aiming for successful FDA compliance. They are adept at managing the documentation and procedural aspects necessary for smooth operations and market access.

Website: greenleafhealth.com

HQ: Washington, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 2,500

Included Services: FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders

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Intertek

Intertek is a global leader in Total Quality Assurance, offering a wide range of services to support businesses in the US agent FDA directory.

Intertek provides comprehensive testing, inspection, and certification services. As a trusted partner for businesses operating within the US agent FDA directory, Intertek ensures compliance and quality across various industries. Their expertise helps clients navigate complex regulatory landscapes and bring safe, compliant products to market efficiently. With a global presence and a commitment to excellence, Intertek is dedicated to assuring the quality and safety of products worldwide.

Website: intertek.com

HQ: London, GB

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 2,100

Included Services: FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders

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TÜV SÜD

TÜV SÜD is a leading technical service provider offering inspection, certification, testing, and training services. They are a trusted partner for businesses seeking to ensure safety, quality, and compliance.

TÜV SÜD is a globally recognized leader in technical services, dedicated to enhancing safety, quality, and sustainability across various industries. With a rich history and a commitment to excellence, they provide comprehensive solutions including inspection, testing, certification, and training. For businesses operating within the US agent FDA directory, TÜV SÜD offers specialized expertise to navigate complex regulatory landscapes. Their services are designed to help clients achieve and maintain compliance with stringent FDA regulations, ensuring product safety and market access. They act as a crucial partner in the product lifecycle, from development to market release and beyond. Leveraging extensive knowledge and a global network, TÜV SÜD empowers organizations to meet international standards and customer expectations. Their independent assessments and certifications provide confidence and credibility, fostering trust between businesses and consumers. They are committed to driving progress and innovation while upholding the highest standards of integrity and technical proficiency.

Website: tuvsud.com

HQ: Peabody, DE

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 2,200

Included Services: FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders

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BSI

BSI is a global leader in standards development, training, and certification. They help organizations improve performance, manage risk, and achieve sustainable growth through internationally recognized standards.

BSI (British Standards Institution) is dedicated to accelerating progress towards a sustainable world by developing and implementing standards that drive excellence across industries. They offer a comprehensive range of services including auditing, certification, training, and consulting, helping businesses enhance quality, safety, and efficiency. With a focus on innovation and digital trust, BSI supports organizations in navigating complex challenges related to cybersecurity, data privacy, and artificial intelligence. Their expertise extends to environmental management, occupational health and safety, and supply chain resilience, ensuring compliance and fostering trust. BSI's commitment to shaping a better future is reflected in their global reach and collaborative approach. They work with a diverse community of experts to create standards that address societal challenges and promote sustainable growth, making them a trusted partner for organizations worldwide.

Website: bsigroup.com

HQ: Reston, United Kingdom

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 2,000

Included Services: FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders

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FDA Compliance Group

FDA Compliance Group LLC offers expert FDA consulting services, including mock audits, gap analysis, Form 483 responses, and warning letter assistance. They help FDA-regulated industries maintain compliance.

FDA Compliance Group LLC provides specialized consulting services to help companies navigate and maintain compliance with all FDA requirements. With a team of former FDA employees and industry experts, they offer comprehensive support for mock audits, gap analysis, and responding to FDA Form 483 observations and Warning Letters. Their services extend to FDA labeling and website reviews, ensuring marketing materials and product labels adhere to current regulations. They also assist with S/AER (Serious Adverse Event Reporting) and MDR (Medical Device Reporting), crucial for medical device manufacturers. FDA Compliance Group serves a wide range of FDA-regulated industries, including medical devices, drugs, dietary supplements, clinical trials, and food & tobacco. Their expertise helps clients avoid regulatory actions, product recalls, and facility shutdowns, ensuring operational continuity and product integrity.

Website: fdacompliancegroup.com

HQ: New York, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 1,600

Features: Inspection Support

Included Services: FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders

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FDA Regulatory Consultants

FDAQRC offers expert regulatory compliance solutions for pharma, biotech, and medical device companies globally. They specialize in GxP, inspection readiness, and quality assurance.

FDA Quality and Regulatory Consultants (FDAQRC) is a premier provider of regulatory compliance solutions tailored for pharmaceutical, biotech, and medical device companies worldwide. With over a decade of experience and a global network of over 500 active consultants, FDAQRC offers comprehensive expertise across all GxP areas, addressing diverse industry needs throughout the product life cycle. Their services encompass quality audits, mock inspections, gap assessments, remediation, and specialized offerings like Qualified Persons (QP) services for UK and EU drug releases. FDAQRC also provides robust staffing solutions, connecting companies with highly skilled Quality and Regulatory professionals for permanent, interim, and contract roles. FDAQRC is committed to ensuring client compliance and product release efficiency. They leverage their extensive market knowledge and global network to source qualified candidates and consultants, facilitating a seamless recruitment and compliance process. With a new office in Northern Ireland, FDAQRC continues to expand its global footprint to better support healthcare innovation.

Website: fdaregulatoryconsultants.com

HQ: Cedar Park, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 1,700

Features: Inspection Support

Included Services: FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders

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FDA Imports Pro

Regulatory & legal consulting firm with over 100 years of direct FDA experience, specializing in FDA-regulated imports: U.S. Agent services, import alerts & refusals, facility registration, customs & border enforcement, labeling & claims review, and legal defense.

FDAImports.com is a compliance expert with over 100 years of direct FDA experience, specializing in helping companies of all sizes navigate U.S. regulatory requirements for highly-regulated commodities. Their regulatory specialists and affiliated attorneys represent proven consulting and legal experience, integrated into a single source for solving the problems involved in bringing products to the highly-regulated United States market. They efficiently handle highly complex technical, regulatory, and legal issues and provide individual solutions for businesses around the world.

Website: fdaimports.com

HQ: Los Angeles, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 1,400

Features: Inspection Support

Included Services: FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders

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FDA Compliance Solutions

FDAQRC provides expert regulatory compliance solutions for pharmaceutical, biotech, and medical device companies globally. They offer GxP compliance, inspection readiness, quality assurance, and staffing services.

FDA Quality and Regulatory Consultants (FDAQRC) is a premier provider of regulatory compliance solutions tailored for pharmaceutical, biotech, and medical device companies worldwide. With over a decade of experience and a global network of over 500 active consultants, FDAQRC excels in all GxP areas, addressing diverse industry needs across product life cycles. Their comprehensive service offerings include quality audits, mock inspections, gap assessments, remediation services, and staffing solutions for both employers and employees. FDAQRC specializes in connecting clients with highly qualified professionals, including former FDA employees and industry leaders, ensuring successful placements for permanent, interim, and contract roles. FDAQRC is committed to supporting clients through every stage of the regulatory compliance process. They have recently expanded their services to include Qualified Persons (QP) services for UK and EU drug releases, further enhancing client compliance and product release efficiency. With a focus on quality and science-backed processes, FDAQRC delivers optimized outcomes and maintains long-lasting client relationships.

Website: fdaqrc.com

HQ: Cedar Park, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 1,800

Included Services: FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders

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FDA Regulatory Affairs

RAPS is the leading global authority for professionals dedicated to the regulatory field. They offer resources and support for navigating FDA regulations and compliance.

The Regulatory Affairs Professionals Society (RAPS) is the premier global organization for those working in regulatory affairs. They provide essential resources, training, and community for professionals navigating the complex landscape of regulatory compliance, particularly within the US FDA framework. RAPS is dedicated to advancing the regulatory profession and ensuring public health and safety through effective regulatory practices. Their offerings are designed to support individuals and organizations in understanding and adhering to critical regulatory requirements.

Website: fdaregulatoryaffairs.com

HQ: Boston, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Retainer

Starting from: USD 1,900

FDA Services: Registration Support

Included Services: FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders

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Boyd Consultants

Regulatory affairs firm offering U.S. Agent services for foreign drug and device manufacturers: handles FDA liaison, inspection coordination, registration/filing support, and submission document signing.

Boyd Consultants (Boyds) is a regulatory affairs and biotech consultancy specializing in drug development and regulatory affairs. They assist global biopharma firms with FDA submissions (INDs, NDAs, BLAs, etc.), offer US Agent / Authorized Representative services, gap assessments, and lifecycle regulatory strategy. They act as US agent, liaise with FDA, support registrations and device/drug sponsor communications, and help with inspection coordination.

Website: jtboyd.com

HQ: US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 3–14 days

Pricing model: Custom pricing

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ProPharma Group

ProPharma Group is a leading global regulatory sciences consulting firm specializing in FDA regulatory affairs, clinical research, and quality & compliance. They offer end-to-end support across the full product lifecycle for drugs, biologics, medical devices, and diagnostics.

ProPharma Group is a premier global regulatory sciences consulting firm dedicated to improving patient health and safety by helping companies navigate the complexities of drug development and regulatory approval. With extensive expertise across the full product lifecycle, they provide strategic solutions for FDA regulatory consulting, clinical research, quality & compliance, pharmacovigilance, and medical information. Their services encompass a wide range of critical areas, including FDA meeting consulting, regulatory operations, and advertising & promotional review. ProPharma's team of science-based regulatory consultants possesses deep knowledge of FDA's regulatory framework, consistently achieving successful outcomes for clients through detailed regulatory strategies and flawless execution of FDA meetings. They have a proven track record of thousands of successful FDA interactions over 40 years. ProPharma Group also excels in clinical research solutions, offering industry-leading support for multi-phase clinical trials. Their commitment to quality and compliance ensures that products are brought to market efficiently and maintain optimal regulatory status throughout their lifecycle. They partner with clients to streamline the regulatory process, overcome challenges, and achieve business objectives, making them a trusted partner for advancing therapies and ensuring patient access to essential medicines.

Website: propharmagroup.com

HQ: US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 3–14 days

Pricing model: Custom pricing

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Global Import Agent

Global Import Agent provides expert US regulatory compliance consulting for food, beverages, supplements, and cosmetics. They simplify FDA requirements, ensuring smooth market entry and ongoing compliance for international businesses.

Global Import Agent specializes in navigating complex US FDA regulations for international businesses importing food, beverages, dietary supplements, cosmetics, and medical devices. They offer comprehensive services including FDA facility registration, acting as your official US Agent, and ensuring compliance with FSVP, labeling, and import requirements. Their expertise helps prevent costly delays, detentions, and refusals by managing details like Prior Notice filing, Import Alert removal, and USDA import requirements. Whether you are a startup or a global supplier, Global Import Agent provides the regulatory guidance and hands-on support needed to expand into the US market with confidence. They are committed to simplifying import compliance, allowing clients to focus on business growth while ensuring all products meet legal and safety obligations before entering the US market.

Website: globalimportagent.com

HQ: Kirkcaldy, GB

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 3–14 days

Pricing model: Custom pricing

Product Types: Food, Cosmetics, Medical Devices

FDA Services: Registration Support

Features: Inspection Support

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FDA Agent Pro

FDA Agent Pro provides services for FDA-regulated industries, including facility registration, product listing, and export certifications. They facilitate submissions to the U.S. Food and Drug Administration.

FDA Agent Pro is a specialized service catering to businesses within FDA-regulated sectors. They offer comprehensive support for essential administrative processes, including facility registrations, product listings, and the generation of export certifications. Their expertise ensures smooth and compliant submissions to the U.S. Food and Drug Administration (FDA), leveraging systems designed to manage critical information for food, biologics, drugs, medical devices, and more. The FDA Industry Systems (FIS) platform, which FDA Agent Pro utilizes, has been operational since October 16, 2003, providing 24/7 access for industry submissions. This system was partly developed in response to the Bioterrorism Act of 2002, emphasizing the importance of robust information management for public health and safety. FDA Agent Pro helps clients navigate these requirements, ensuring adherence to regulations for food facility registration and prior notice for imported food products.

Website: fdaagentpro.com

HQ: United States, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 3–14 days

Pricing model: Custom pricing

FDA Services: Registration Support

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MDSS

MDSS provides expert regulatory representation and compliance services for medical device and IVD manufacturers globally. They specialize in EU Authorized Representation, FDA U.S. Agent services, and QMSR compliance.

MDSS is a seasoned provider of regulatory representation and compliance solutions, with over 30 years of experience assisting medical device and IVD manufacturers. They offer comprehensive In-Country Representation services across key global markets including the EU, UK, Switzerland, USA, and Australia. For the US market, MDSS acts as an official FDA U.S. Agent, serving as a crucial liaison for non-U.S. manufacturers to ensure compliance with FDA regulations and facilitate seamless market access. They also provide expert guidance on the FDA's Quality Management System Regulation (QMSR), helping companies navigate the transition to ISO 13485:2016. MDSS is dedicated to simplifying complex regulatory landscapes, allowing clients to focus on innovation and core business operations. Their services are designed to minimize risk, avoid costly delays, and ensure adherence to international standards.

Website: mdss.com

HQ: Schleswig, DE

Jurisdictions: US

Countries: US

Languages: English, German, French, Spanish

Response SLA: 48 hours

Onboarding time: 3–14 days

Pricing model: Custom pricing

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US Agent Pros

FDA U.S. Agent representation and compliance services for foreign FDA-regulated manufacturers, including official contact designation, registration/listing, labeling review, inspection support and product compliance.

US Agent Pros provides U.S. Agent services as required by law for foreign companies that manufacture, process, pack, or store FDA-regulated products. They manage FDA communications, assist during inspections, handle registration/listing, labeling reviews, adverse event reporting, and other compliance tasks. They serve as the official point of contact for foreign FDA-regulated manufacturers, ensuring proper communication and compliance with FDA requirements.

Website: usagentpros.com

HQ: United States, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 3–14 days

Pricing model: Custom pricing

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Catain Labs

Catain Labs offers comprehensive FDA regulatory consulting, eCTD publishing, and US Agent services for pharmaceutical and biotech companies. They simplify compliance and accelerate approvals.

Catain Labs specializes in guiding pharmaceutical, biotechnology, and healthcare companies through the complex U.S. regulatory landscape, making FDA compliance straightforward, reliable, and efficient. With expertise in IND, NDA, ANDA, NDC, FEI, GDUFA, and eCTD submissions, they provide end-to-end regulatory support tailored to business needs. For foreign companies, Catain Labs serves as the official U.S. Agent, managing all FDA communication, submissions, and compliance requirements seamlessly. They also handle the entire registration and annual renewal process for manufacturing, repacking, or distribution facilities, ensuring continuous compliance. Their services include preparing, formatting, validating, and submitting applications in eCTD format for smooth FDA review, and providing complete support for applying for, assigning, and maintaining National Drug Code (NDC) numbers. Catain Labs acts as a regulatory partner, helping clients minimize risks, reduce delays, and achieve approvals with confidence.

Website: catainlabs.com

HQ: United States, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 3–14 days

Pricing model: Custom pricing

FDA Services: Registration Support

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Pineprep

Pineprep offers comprehensive regulatory services for medical device and IVD companies, specializing in FDA US Agent representation, Certificate to Foreign Government (CFG), Apostille & Legalization, and expert consulting to facilitate global market access.

Pineprep is a dedicated regulatory consulting firm assisting medical device and IVD companies in navigating complex global regulations. They specialize in securing FDA US Agent representation, essential for foreign establishments importing devices into the US. Pineprep also facilitates the acquisition of Certificates to Foreign Government (CFG), proving FDA compliance and enabling market entry in various international regions. Furthermore, Pineprep handles the apostille and legalization of essential documents, ensuring their validity for use in countries worldwide. Their expert consulting services cover the entire regulatory journey, from initial strategy development to post-market surveillance. With a focus on pragmatic solutions and efficient processes, Pineprep aims to streamline compliance and accelerate time-to-market for their clients, acting as a trusted partner in their regulatory endeavors.

Website: pineprep.com

HQ: Arlington, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 3–14 days

Pricing model: Custom pricing

FDA Services: Registration Support

Features: Inspection Support

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Sterling Medical Devices

Sterling Medical Devices is a US-based provider of custom sterile surgical packs, procedure trays, and contract packaging for medical devices. They offer GMP-compliant facilities and expertise in packaging and manufacturing.

Sterling Medical Devices specializes in contract packaging of private-labeled medical devices, custom sterile surgical packs, and procedure trays. With over 100 years of combined experience, they focus on delivering safe, efficacious, and high-quality products to the medical industry. They offer comprehensive solutions designed to be cost-effective, reduce clinician time, eliminate waste, and manage space constraints, ultimately ensuring efficient quality of care for patients. Sterling Medical Devices understands and navigates complex regulatory requirements from bodies like the FDA and ISO, ensuring testing, data, and documentation are prepared in advance. Operating from GMP-compliant facilities, their team of packaging and manufacturing experts collaborates closely with clients to understand specific challenges and develop unique solutions. They also provide stocking agreements and emergency drop shipments to accommodate varying storage and distribution needs. As a minority-owned business with over 36 years of experience, Sterling Medical Devices is committed to exceeding customer expectations and improving patient lives through their efficient and cost-effective operations.

Website: sterlingmedicaldevices.com

HQ: San Diego, CA, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 3–14 days

Pricing model: Custom pricing

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FDA Compliance Group LLC

FDA Compliance Group LLC is a U.S.-based FDA compliance and regulatory consulting firm serving FDA-regulated companies (from startups to multinationals) in the U.S. and internationally. Led by Martina LaGrange (former FDA Field Investigator/Medical Device Specialist), the team supports medical devices, drugs/pharma, food & tobacco, dietary supplements, and clinical trials across the full compliance lifecycle.

EAS Consulting Group is a premier provider of regulatory compliance solutions for industries regulated by the FDA and USDA. They specialize in guiding pharmaceutical, medical device, biotechnology, and food companies through complex regulatory landscapes. Their services encompass consulting, submissions, auditing, training, and legal support, with a particular focus on acting as a US Agent for foreign firms importing FDA-regulated products into the United States. EAS assists clients with a wide range of import challenges, including prior notice, labeling accuracy, LACF registration, and FSMA supplier qualifications. They also prepare foreign firms for FDA inspections through mock inspections and help address violations found during past inspections. Furthermore, EAS provides expertise in responding to FDA Form 483 observations and ensuring compliance with 21 CFR Part 11 for electronic records and signatures, crucial for modern life science operations. With a team of experienced consultants, EAS Consulting Group helps clients navigate regulatory requirements, ensure product compliance, and facilitate market entry into the US. They are dedicated to providing expert guidance and practical solutions to meet the evolving demands of FDA regulations.

Website: fdacg.com

HQ: Broomfield, Colorado, US

Jurisdictions: US

Countries: United States, International (remote)

Languages: English

Response SLA: 48 hours

Onboarding time: 1–14 days

Pricing model: Custom pricing

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Regulatory Solutions Inc

Regulatory Solutions Inc. is a Canadian consulting firm specializing in obtaining Health Canada approvals for pharmaceuticals, natural health products, and medical devices. They offer strategic regulatory planning and compliance support.

Founded in 2001, Regulatory Solutions Inc. (RSI) is a Canadian pharmaceutical regulatory approval and compliance consulting company with extensive success in obtaining Health Canada approvals. They specialize in prescription drugs, natural health products, and medical devices, ensuring timely approvals through strategic planning and expert submission support. RSI's team of consultants possesses diverse skills and a strong track record for navigating Health Canada's requirements, including electronic CTD format and the Common Electronic Submissions Gateway (CESG). They assist clients with new and generic drug approvals, Class II, III, and IV medical device applications, and natural health product submissions. Beyond initial approvals, RSI provides ongoing support for post-marketing changes, Good Manufacturing Practices (GMP), and Quality System services. They also help companies establish regulatory affairs departments and quality assurance systems in Canada, and supervise GMP audits by Health Canada. Their expertise extends to advising on regulatory compliance issues and creating Standard Operating Procedures (SOPs).

Website: regulatorysolutions.ca

HQ: Caledon, Canada

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 3–14 days

Pricing model: Custom pricing

Features: Inspection Support

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FDA Regulatory Experts

RAPS is the leading global authority for professionals engaged in the regulation of healthcare and related products. They offer resources and expertise for FDA regulatory compliance.

The Regulatory Affairs Professionals Society (RAPS) is the premier global organization for those who work in the regulation of healthcare and related products. They are dedicated to advancing the profession and supporting individuals in navigating the complex landscape of regulatory affairs. RAPS provides a wealth of resources, including training, networking opportunities, and up-to-date information, specifically for professionals dealing with FDA regulations and compliance. Their expertise is invaluable for companies seeking to understand and adhere to FDA requirements for product approval and market access.

Website: fdaregulatoryexperts.com

HQ: Washington, DC, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 3–14 days

Pricing model: Custom pricing

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Medical Device Regulatory Services

Emergo by UL offers comprehensive regulatory consulting and market access services for medical devices and IVDs globally. They specialize in device registration, human factors, privacy, and security, helping clients navigate complex international compliance requirements.

Emergo by UL is a leading provider of regulatory consulting and market access services for medical device and IVD companies worldwide. With a deep understanding of global regulatory landscapes, they assist clients in achieving compliance and facilitating market entry across various regions. Their core services include medical device registration, in-country representation, and post-market surveillance. They also offer specialized expertise in human factors research and design, ensuring products are safe and effective for end-users. Furthermore, Emergo by UL provides crucial privacy and security consulting, addressing data protection requirements like HIPAA and GDPR. Leveraging a suite of digital tools and extensive industry knowledge, Emergo by UL helps streamline regulatory affairs and quality assurance activities. They are dedicated to supporting manufacturers throughout the entire product lifecycle, from initial development to global market access, ensuring a smooth and compliant journey.

Website: mdrs.com

HQ: St. Louis, US

Jurisdictions: US

Countries: US

Languages: English, French, German, Spanish

Response SLA: 48 hours

Onboarding time: 3–14 days

Pricing model: Custom pricing

FDA Services: Registration Support

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Regulatory Compliance Associates

Regulatory Compliance Associates (RCA), a Nelson Labs company and part of the Sotera Health group, provides comprehensive regulatory compliance consulting for the life science industry. They assist pharmaceutical and medical device companies in navigating complex regulatory landscapes, from initial product development through clearance and approval. RCA's expertise spans critical areas such as FDA submissions (including 510(k)), U.S. Agent services, CAPA management, and compliance assurance. They are dedicated to helping clients meet evolving regulatory requirements and achieve quality assurance goals. With a strong commitment to safeguarding global health, RCA partners with over 5,000 customers worldwide, including a significant portion of top medical device and pharmaceutical companies. Their team of passionate and high-performing consultants offers tailored solutions to address regulatory, compliance, and remediation challenges, ensuring clients can bring safe and effective products to market.

Website: rcainc.com

HQ: Wisconsin, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 3–14 days

Pricing model: Custom pricing

FDA Services: Registration Support

Features: Inspection Support

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FDA Registration Services

FDA Registration Services facilitates submissions to the U.S. Food and Drug Administration, including facility registrations and product listings for various industries.

FDA Registration Services provides a streamlined process for making essential submissions to the U.S. Food and Drug Administration (FDA). This includes facility registrations, product listings, and other required notifications, ensuring compliance with federal regulations. The FDA Industry Systems (FIS) platform has been operational 24/7 since October 16, 2003, and was developed in response to the Bioterrorism Act of 2002. This initiative prioritized improved information management to safeguard the food supply, mandating the development of systems for facility registration and prior notice for imported food products. Services cover a range of FDA-regulated industries, including food, biologics, drugs, medical devices, and cosmetics. Specific modules and forms are available for Acidified/Low Acid Canned Foods (LACF), Biologics Export Certification, Export Listing, and various other certification and tracking systems. Key systems supported include the Voluntary Cosmetic Registration Program, Blood Establishment Registration, Human Cell and Tissue Establishment Registration, Drug Registration and Listing, and Medical Device Registration and Listing for firms.

Website: fdaregistrationservices.com

HQ: United States, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 48 hours

Onboarding time: 3–14 days

Pricing model: Custom pricing

FDA Services: Registration Support

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Medical Device Academy

Medical Device Academy, Inc. is a quality and regulatory consulting firm specializing in FDA 510(k) submissions, quality system implementation, and FDA US Agent services. They help small device companies prepare FDA 510(k) submissions using the eSTAR template, implement quality systems for FDA, ISO 13485, and MDSAP compliance, conduct quality system audits, and provide FDA US Agent designation services.

Medical Device Academy, Inc. is a quality and regulatory consulting firm with a team of ten professionals working virtually. They specialize in helping small device companies prepare FDA 510(k) submissions using the eSTAR template, preparing FDA pre-submissions using the PreSTAR template, implementing new quality systems for compliance with FDA, ISO 13485, and MDSAP, and conducting quality system audits. Their services include FDA US Agent services, CE Marking preparation, Canadian License applications, and regulatory pathway analysis for US, European, and Canadian markets. They also provide training courses and webinars for medical device professionals. Clients with urgent needs where time to market is critical turn to Medical Device Academy for their expertise in FDA regulations and quality systems.

Website: medicaldeviceacademy.com

HQ: US

Jurisdictions: US

Countries: US

Languages: English

FDA Services: Registration Support

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Certified Laboratories

Certified Laboratories offers comprehensive ISO 17025-accredited laboratory testing and research services across North America. They specialize in food & beverage, cosmetic, OTC, and supplement industries, ensuring product safety and quality.

Certified Laboratories, a Certified Group company, provides innovative scientific solutions and expertise to businesses worldwide. With over 30 ISO 17025-accredited testing laboratories across North America, they offer a comprehensive range of services including microbiology, analytical chemistry, contract research, and certification & audit services. They partner with customers to deliver trustworthy, accurate lab testing and research, focusing on ensuring product safety and quality. Their expertise extends to critical industries such as food & beverage, cosmetics, over-the-counter (OTC) drugs, dietary supplements, and botanicals. Certified Laboratories is committed to helping clients navigate complex regulatory landscapes, including FDA, USDA, and USP standards. Through their collaboration with Food Safety Net Services (FSNS), another Certified Group company, they offer specialized services like environmental monitoring, food safety training, and FDA DWPE sampling and testing. Their goal is to support clients' safety and quality programs, enabling them to bring trusted products to market.

Website: certified-laboratories.com

HQ: US

Jurisdictions: US

Countries: US

Languages: English

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Pharmaceutical Development Group, Inc.

Pharmaceutical Development Group (PDG) offers expert FDA regulatory consulting and strategic drug development services. They partner with life sciences companies to navigate complex regulatory pathways, ensuring product safety, efficacy, and commercial success.

Pharmaceutical Development Group (PDG), a subsidiary of Biotech Research Group Corporation, provides comprehensive FDA regulatory consulting and strategic drug development services. With extensive experience dating back to 1999, PDG assists drug and medical device companies in navigating the complexities of the FDA, from early-stage development through post-launch activities. Their expertise spans a wide range of services, including Pre-IND meetings, IND/SPA submissions, clinical trial design, NDA submissions (505(b)(1)/505(b)(2)), and generic drug applications (505(j) ANDAs). PDG also offers specialized consulting for medical devices, covering submissions like 510(k) and PMA, as well as facility inspection readiness and mock audits. PDG's team comprises seasoned professionals, including former FDA regulatory scientists and chemists, who leverage their deep understanding of regulatory requirements to maximize the safety, efficacy, and commercial value of their clients' products. They are dedicated to serving as long-term regulatory partners throughout the product lifecycle, ensuring compliance with cGMP, QSR, and other relevant international standards.

Website: pharmdevgroup.com

HQ: US

Jurisdictions: US

Countries: US

Languages: English

Features: Inspection Support

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RQMIS

RQMIS provides expert regulatory, clinical, and quality consulting for medical device companies. They specialize in FDA submissions, US Agent services, and navigating complex regulatory pathways to ensure market success.

RQMIS is a premier consulting firm dedicated to guiding medical device and IVD companies through the complexities of regulatory compliance and market access. With a strong focus on FDA submissions, including 510(k) repairs and DeNovo applications, RQMIS ensures your products meet all necessary requirements for US market entry. They offer specialized US Agent services, acting as your official correspondent with the FDA, which is critical for foreign establishments. Their expertise extends to managing FDA inspections, addressing warning letters, and providing comprehensive support for combination products. RQMIS leverages deep industry knowledge to streamline the path to market, offering solutions for product definition, design, manufacturing, and post-market surveillance. Whether you need assistance with quality management systems, clinical services, or navigating European regulations as an Authorized Representative, RQMIS is equipped to deliver tailored strategies for success.

Website: rqmis.com

HQ: Amesbury, USA

Jurisdictions: US

Countries: US

Languages: English

FDA Services: Registration Support

Features: Inspection Support

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Sotas

Sotas provides expert US FDA Agent services for foreign medical device manufacturers, ensuring smooth market entry and compliance with US regulations. They act as a crucial liaison with the FDA for inspections, recalls, and adverse event reporting.

Sotas offers specialized US Agent services to foreign medical device manufacturers seeking to enter the U.S. market. As an appointed FDA U.S. Agent, Sotas acts as the primary point of contact between your company and the U.S. Food and Drug Administration (FDA), facilitating efficient communication regarding regulatory matters such as inspections, product recalls, and adverse event reporting. They understand the critical nature of these requirements and are dedicated to ensuring timely responses and professional handling of all FDA communications. Their expertise in navigating the complexities of FDA regulations helps to minimize delays and ensure a smooth market entry for your medical devices. Sotas partners with trusted U.S. Agents to manage regulatory communications and responsibilities, allowing you to focus on your core business operations while maintaining compliance with FDA standards. They are committed to providing customized compliance solutions throughout the entire quality and regulatory spectrum, absorbing the complexities of the ever-changing regulatory landscape so you don't have to.

Website: sotas.co.uk

HQ: Haverfordwest, GB

Jurisdictions: US

Countries: US

Languages: English

FDA Services: Registration Support

Features: Inspection Support

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Artixio

Artixio offers scalable regulatory consulting solutions for the entire product lifecycle, powered by AI. They provide global regulatory expertise and insourcing models to support critical needs in the life sciences industry.

Artixio provides comprehensive regulatory consulting services designed to support the entire product lifecycle, from initial concept through launch and post-launch activities. Leveraging AI-enabled platforms, their flexible business models facilitate global scaling and timely market entry. With a global team of over 250 regulatory experts across 120+ countries, Artixio specializes in New Product Registration, Post Approval Maintenance, Dossier Preparation, Submission, and Health Authority Liaison. Their expertise spans a wide range of products, including pharmaceuticals, medical devices, biologics, veterinary products, and consumer goods, ensuring compliance with Health Authority requirements. Artixio's Insourcing Model is designed to address regional resource gaps with speed, accuracy, and agility. They offer short-, mid-, and long-term contingent staffing solutions to meet critical, time-sensitive needs within the life sciences sector. Their services encompass Regulatory Affairs, Regulatory Intelligence, and Regulatory Operations, including product registration, technical medical writing, lifecycle maintenance, advertising review, artwork labeling, publishing submissions, and legal representation.

Website: artixio.com

HQ: US

Jurisdictions: US

Countries: US

Languages: English

FDA Services: Registration Support

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TechLink International LLC

TechLink International provides essential FDA compliance services, including US Agent representation, Initial Importer services, and Registration & Listing for medical devices and cosmetics. They ensure efficient communication with the FDA and help foreign establishments navigate US import regulatio

TechLink International LLC specializes in guiding foreign establishments through the complexities of FDA compliance for importing products into the United States. They offer crucial services such as acting as the US Agent, which involves efficient communication with the FDA, and serving as the Initial Importer, a requirement for the release of medical devices. Their expertise extends to Establishment Registrations and Product Listings for medical devices, as well as compliance with the Modernization of Cosmetics Regulation Act (MoCRA), including handling adverse event reporting and assisting with record access. TechLink International acts as a vital liaison, ensuring foreign manufacturers meet all legal obligations and facilitating smooth market entry. As a US Agent, TechLink International is authorized to receive legal notifications and official documents on behalf of manufacturers or importers. They are committed to preventing penalties and fines by ensuring adherence to FDA regulations, thereby safeguarding market access and avoiding product recalls. Their services are designed to streamline the import process and ensure continuous compliance with US regulatory requirements.

Website: fdainitialimporter.techlinkinternational.com

HQ: US

Jurisdictions: US

Countries: US

Languages: English

FDA Services: Registration Support

Features: Inspection Support

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Liberty Management Group

Liberty Management Group is a leading US FDA agent and registration service provider for foreign food, drug, and medical device establishments. They offer expert guidance on FDA regulations, ISO certifications, and quality systems.

Liberty Management Group (LMG) is a premier US-based consultancy specializing in FDA regulations and quality system compliance for international businesses. They serve as a crucial US FDA Agent for foreign food, drug, and medical device establishments looking to market their products in the United States. LMG ensures seamless communication with the FDA, assists with facility registration, and helps navigate complex regulatory requirements. With extensive experience, LMG offers comprehensive FDA registration services for food facilities, drug establishments, and medical devices. They also provide support for cosmetic registrations under MoCRA. Their expertise extends to ISO certifications, including ISO 9001 and ISO 13485, and GMP compliance. LMG is dedicated to helping clients achieve regulatory approval efficiently and cost-effectively, positioning themselves as a trusted partner in global market access. Their services are designed to meet the mandatory requirements for foreign entities, including DUNS number verification for drug establishments and confirmation of registration details. LMG's commitment to customer focus and leadership in regulatory affairs makes them an invaluable resource for businesses seeking to enter or maintain compliance within the US market.

Website: libertymanagement.us

HQ: Aurora, USA

Jurisdictions: US

Countries: US

Languages: English

FDA Services: Registration Support

Features: Inspection Support

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Biotech Research Group

Biotech Research Group (BRG) is a full-service regulatory and product development consulting firm specializing in FDA compliance, biologics, medical devices, and pharmaceuticals. They offer expert guidance for product development and clinical research.

Biotech Research Group (BRG) is a comprehensive regulatory and product development consulting firm with a global reach, serving clients in over 60 countries. They specialize in providing efficient and expeditious services for a wide range of products, including pharmaceuticals, medical devices, healthcare IT, and biologics. BRG is a leader in FDA regulations and compliance, offering expert support for various FDA submissions such as BLA, PMN, PMA, 510k, ANDA, NDA, and IND. Their services encompass the entire product development lifecycle, from initial research and clinical trials to post-market surveillance and adverse event reporting. BRG's team of experts possesses diverse therapeutic expertise and can assist with toxicology, pharmacokinetics, statistics, epidemiology, and pharmacovigilance. They tailor each product development or clinical research plan to meet specific client budgets and timelines. BRG is particularly adept at navigating complex FDA requirements, including those for biologics (BLA, vaccines, cellular & gene therapy) and medical devices (PMN, PMA, 510k). They also provide crucial support for pharmaceutical consulting, including ANDA, NDA, OTC, and IND applications. With a focus on quality management and streamlined processes, BRG ensures clients receive the best solutions for bringing their products to market safely and effectively.

Website: biotechresearchgroup.com

HQ: USA

Jurisdictions: US

Countries: US

Languages: English

Response SLA: Custom hours

FDA Services: Registration Support

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Facet Life Sciences

Facet Life Sciences is a regulatory affairs and product development strategy partner for emerging biotech and science companies. They guide clients through FDA pathways for drug, biologic, and medical device development.

Facet Life Sciences specializes in guiding small life science companies through the complex journey of drug, biologic, and medical device development. They offer tailored solutions for every stage, from initial concept through commercialization, focusing on nimble, entrepreneurial approaches to navigate FDA's regulatory pathways with precision and expertise. Their services include acting as a US Agent, providing regulatory strategy and development guidance, gap analysis, medical writing for submission documents, meeting facilitation with the FDA, and regulatory submission leadership. Facet fosters collaborative relationships with the FDA (CDER, CBER, and CDRH) on behalf of their clients to progress products through development and secure market acceptance. With a team bringing decades of experience in product development, nonclinical, clinical, CMC, regulatory affairs, and commercial launch, Facet helps create and execute effective development plans and launch strategies. They are committed to aggressive, scientifically sound progress, aligning strategies with client resources and business objectives to translate science into product value and answers for investors or partners.

Website: facetlifesciences.com

HQ: Wayne, US

Jurisdictions: US

Countries: US

Languages: English

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Dunn Regulatory Associates, LLC

Dunn Regulatory Associates, LLC offers expert US Agent services for non-US firms entering the US pharmaceutical market. Leverage their scientific acumen and regulatory expertise for effective FDA communications and compliance.

Dunn Regulatory Associates, LLC provides specialized US Agent services, acting as a reliable and competent representative for international companies seeking to enter the US pharmaceutical market. Their team of consultants possesses deep scientific acumen and regulatory expertise, strategically located in the Washington, DC metropolitan area, making them an ideal choice for global clients. They streamline product development from discovery to market by integrating scientific knowledge, business strategy, and regulatory expertise. Dunn Regulatory Associates, LLC has a proven track record in resolving complex regulatory situations for Rx and OTC pharmaceuticals, biopharmaceuticals, and devices. Their services include gap analysis of regulatory submissions, ensuring compliance with all applicable laws and regulations, facilitating effective communications with the FDA, and participating in FDA meetings and teleconferences. Their consultants are experienced US and EU regulatory strategists, offering pragmatic approaches to regulatory challenges, developing concise strategies, and leading regulatory meetings. Dunn Regulatory Associates, LLC is committed to providing sound solutions and expert advice to companies across the globe, ensuring a smoother path to market entry and regulatory success.

Website: dunnregulatory.com

HQ: Vienna, USA

Jurisdictions: US

Countries: US

Languages: English

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Asia Actual, LLC

Asia Actual provides expert medical device regulatory and market access consulting for Asian markets. They help manufacturers navigate complex registration processes and accelerate time to revenue.

Asia Actual specializes in assisting medical device manufacturers in gaining and maintaining access to dynamic Asian markets. With offices staffed by experienced, bilingual regulatory and market access professionals in major Asian capital cities, they offer comprehensive support for device registration, post-market vigilance, importing, and commercialization. Their services are designed to simplify the registration process and accelerate your time to revenue across various Asian countries, including Australia, China, India, Japan, Malaysia, Philippines, Singapore, and more. Asia Actual distinguishes itself through outstanding personnel, clear communication, and transparent operations, making them a premier option for market access solutions in the region. They offer tailored guidance on specific regulatory requirements, such as MAH responsibilities in Sri Lanka, fast-track pathways in the UK and Singapore, and navigating regulations in the Philippines and Malaysia. Contact Asia Actual for a free consultation to explore your market access options in Asia.

Website: americasactual.com

HQ: Austin, US

Jurisdictions: US

Countries: US

Languages: English

FDA Services: Registration Support

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Provision Consulting Group, Inc.

Provision FDA is a U.S. FDA regulatory consulting firm specializing in helping businesses, especially those outside the U.S., navigate FDA regulations for market entry and compliance. They offer services like product registration, US agent representation, and compliance advisory.

Provision FDA is a specialized U.S. FDA regulatory consulting firm dedicated to assisting companies, particularly those located internationally, in successfully entering and complying with the U.S. market. With over 11 years of experience, they offer a comprehensive suite of services including FDA registration status verification, acting as a U.S. Agent, and providing expert guidance on innovative products, medical devices, drugs, and food & beverages. They are recognized as an Amazon (USA) SPN Partner and focus on helping clients overcome regulatory hurdles. Their expertise extends to navigating complex regulations like MoCRA for cosmetics and ensuring compliance with Quality System Regulations (QSR) for medical device manufacturers. Provision FDA emphasizes direct consultant involvement to ensure client success in the U.S. market, offering tailored strategies for product registration, compliance, and market access to major U.S. retailers.

Website: provisionfda.com

HQ: Chino Hills, US

Jurisdictions: US

Countries: US

Languages: English

FDA Services: Registration Support

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GlobalCompliance Solutions Pro

Leading global regulatory compliance consultancy serving medical device manufacturers worldwide with comprehensive regulatory services.

Website: globalcompliance-solutions.com

HQ: Boston, US

Jurisdictions: US

Countries: DE, FR, GB, US

Languages: English, French, German, Spanish

Response SLA: 24 hours

Onboarding time: 7–30 days

Pricing model: Custom pricing

FDA Services: Registration Support

Features: Inspection Support, 24/7 Emergency

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MedReg International Pro

Specialized regulatory consultancy providing end-to-end compliance solutions for medical devices, IVDs, and combination products across all major markets.

Website: medreg-international.com

HQ: London, UK

Jurisdictions: US

Countries: DE, FR, GB, US

Languages: English, French, German, Spanish

Response SLA: 24 hours

Onboarding time: 7–30 days

Pricing model: Custom pricing

FDA Services: Registration Support

Features: Inspection Support, 24/7 Emergency

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Regulatory Excellence Partners Pro

Boutique regulatory consultancy offering personalized, high-touch regulatory services for innovative medical device companies and startups.

Website: regulatoryexcellence.com

HQ: San Francisco, US

Jurisdictions: US

Countries: DE, FR, GB, US

Languages: English, French, German, Spanish

Response SLA: 24 hours

Onboarding time: 7–30 days

Pricing model: Custom pricing

FDA Services: Registration Support

Features: Inspection Support, 24/7 Emergency

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DDReg Pharma

DDReg Pharma is a trusted global partner in the life sciences industry, delivering specialized consulting across Regulatory Affairs, Pharmacovigilance, Quality Assurance, and Clinical Research.

DDReg Pharma is a trusted global partner in the life sciences industry, delivering specialized consulting across Regulatory Affairs, Pharmacovigilance, Quality Assurance, and Clinical Research. With expertise spanning multiple regulatory jurisdictions and therapeutic areas, DDReg Pharma helps pharmaceutical, biotechnology, and medical device companies navigate complex regulatory landscapes.

Website: ddregpharma.com

Jurisdictions: US

Product Types: Medical Devices, ivd

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Lachman Consultants

Global Regulatory Compliance Experts. Comprehensive FDA consulting services for pharmaceutical, medical device, and biotechnology companies.

Lachman Consultants is a global regulatory compliance expert firm providing comprehensive FDA consulting services. We specialize in regulatory affairs, quality systems, validation, and compliance for pharmaceutical, medical device, and biotechnology companies. Our team of experienced consultants helps clients navigate complex regulatory landscapes and achieve compliance with FDA regulations.

Website: lachmanconsultants.com

HQ: San Francisco, United States

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Custom pricing

Starting from: USD 1,600

Product Types: Medical Devices, ivd, Drugs

Included Services: FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders

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CENIT Consulting (US FDA Agent)

U.S. FDA Agent for Medical Devices & IVD. Fast, predictable service with 1 business day FDA notice forwarding. Specialized in foreign establishments only.

CENIT Consulting provides comprehensive regulatory guidance for medical device manufacturers navigating complex global compliance landscapes. With over 15 years of experience, they specialize in accelerating market entry for EU and Asian device manufacturers into the US, acting as a dedicated US FDA Agent. Their services encompass end-to-end pathfinding for EU MDR/IVDR and US FDA regulations, including regulatory strategy, gap analysis, risk management, and submission preparation. CENIT Consulting also offers robust support for Quality Management systems, such as ISO 13485, and information security (ISO 27001), ensuring audit-ready documentation and compliance. For foreign manufacturers, CENIT Consulting's role as a US FDA Agent is crucial for efficient communication with the FDA, import coordination, and avoiding costly delays. They emphasize responsiveness and operational continuity, differentiating their services from distributor-based representation and ensuring smooth import processes. Beyond US FDA representation, CENIT Consulting provides PRRC (Person Responsible for Regulatory Compliance) services for EU MDR/IVDR, offering fast onboarding and ongoing compliance support. Their holistic approach ensures that clients can confidently launch and grow their medical devices in key international markets.

Website: cenitconsulting.com

HQ: Houston, US

Jurisdictions: US

Countries: US

Languages: English

Response SLA: 24 hours

Onboarding time: 2–7 days

Pricing model: Onboarding + annual retainer

Starting from: USD 329

FDA Services: Registration Support

Features: Inspection Support

Included Services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders

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Comprehensive Buyer's Guide

1. Who Needs an FDA U.S. Agent for Medical Devices?

FDA regulations (21 CFR Part 807^[1]) require all foreign medical device establishments to designate a U.S. Agent (also called FDA US agent or FDA U.S. agent) when registering with the FDA^[1].

This requirement applies to:

Foreign medical device manufacturers placing devices on the U.S. market^[1] — a FDA US agent is mandatory for registration
Foreign specification developers developing device specifications^[1] — require U.S. agent FDA services
Foreign contract manufacturers manufacturing devices for others^[1] — must appoint a FDA agent for foreign manufacturer
Foreign repackagers/relabelers repackaging or relabeling devices^[1] — need FDA US agent services
Foreign initial distributors/importers importing devices into the U.S.^[1] — require U.S. agent FDA designation

Note: The U.S. Agent must be physically located in the United States^[1] and available during normal business hours^[1]. This requirement applies regardless of device class or premarket approval status^[1].

References

21 CFR Part 807 — Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices (FDA) — 2020-01-01 — 21 CFR 807.40

Frequently Asked Questions

Q1: What does an FDA U.S. Agent do?

An FDA U.S. Agent (also called FDA US agent or U.S. agent FDA) is a person or entity located in the United States who serves as the official point of contact for the FDA regarding a foreign establishment's medical device registration and listing under 21 CFR Part 807^[1]. The U.S. Agent acts as a communications intermediary between the foreign manufacturer and the FDA^[1]. Key responsibilities include: receiving communications from FDA on behalf of the foreign establishment^[1], forwarding FDA communications to the foreign manufacturer in a timely manner^[1], responding to FDA requests for information or documentation^[1], facilitating FDA inspections if required^[1], and supporting administrative tasks related to FDA registration and listing^[1]. The FDA US agent must be physically located in the U.S.^[1] and available during normal business hours^[1] (though some FDA US agent services providers offer 24/7 availability). The agent does not assume liability for the device but serves as a critical communication link.

References

21 CFR Part 807 — Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices (FDA) — 2020-01-01 — 21 CFR 807.40

Q2: Is a U.S. Agent required for all foreign manufacturers?

Yes, FDA regulations (21 CFR Part 807^[1]) require all foreign establishments (manufacturers, specification developers, contract manufacturers, contract sterilizers, repackagers, relabelers, and initial distributors/importers) to designate a U.S. Agent (also called FDA US agent or U.S. agent FDA) when registering with the FDA^[1]. This requirement applies regardless of device class or whether the device requires premarket approval^[1]. The U.S. Agent must be designated at the time of initial registration^[1] and must be maintained as long as the establishment remains registered^[1]. If you're a foreign manufacturer placing medical devices on the U.S. market, you must have a FDA US agent—there are no exceptions to this requirement under current FDA regulations^[1].

References

21 CFR Part 807 — Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices (FDA) — 2020-01-01 — 21 CFR 807.40

Q3: What affects FDA U.S. Agent pricing?

U.S. Agent pricing varies based on several factors: service scope (basic agent services vs. comprehensive support including registration assistance, inspection support, etc.), portfolio size (number of devices and establishments), response expectations (standard business hours vs. 24/7 availability), additional support services (FDA registration and listing support, 510(k) submission assistance, inspection preparation, etc.), and contract terms (annual retainer vs. per-establishment fees). Some providers offer basic agent services for a few hundred dollars per year, while comprehensive packages with additional regulatory support can cost significantly more. Request detailed pricing breakdowns to understand what's included and what incurs additional charges.

Q4: What should I check before choosing a U.S. Agent?

When selecting a FDA U.S. Agent (also called FDA US agent or U.S. agent FDA), evaluate: reliability and track record (how long they've been in business, client references), responsiveness (SLA for forwarding FDA communications^[1], availability during business hours^[1] or 24/7), FDA experience (understanding of FDA processes, relationships with FDA, knowledge of medical device regulations^[1]), change control and notification terms (how they handle changes to your registration^[1], device listings, etc.), technology and communication (online portal for tracking communications, secure document transfer), additional services (if you need registration support^[1], inspection assistance^[1], etc.), and pricing transparency (clear fee structure, no hidden costs). Also verify they're physically located in the U.S.^[1] and can provide a U.S. address and phone number for FDA records^[1].

References

21 CFR Part 807 — Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices (FDA) — 2020-01-01 — 21 CFR 807.40

Q5: Can a U.S. Agent also help with FDA registration steps?

Yes, many U.S. Agent providers offer additional services beyond basic agent representation, including: FDA establishment registration assistance (helping you complete and submit registration forms), device listing support (adding devices to your registration, updating listings), FDA correspondence management (drafting responses to FDA inquiries), inspection support (preparing for FDA inspections, coordinating inspection logistics), and regulatory consulting (advising on FDA requirements, compliance strategies). However, these are typically separate services with additional fees. When evaluating providers, clarify what's included in the base agent fee versus what requires additional payment. Some manufacturers prefer a basic agent and handle registration themselves, while others value comprehensive support from a single provider.

Q6: What happens if my U.S. Agent doesn't forward FDA communications promptly?

Timely communication is critical for FDA compliance^[1]. If your FDA U.S. Agent (also called FDA US agent) fails to forward FDA communications promptly^[1], you may miss important deadlines, requests for information, or inspection notifications^[1], which can result in: delayed device approvals, FDA enforcement actions, registration issues^[1], and potential market access problems. FDA expects foreign manufacturers to respond to communications within specified timeframes^[1], and delays can impact your ability to maintain compliance. When selecting a U.S. agent FDA, verify their SLA for forwarding communications (many FDA US agent services providers commit to same-day or 24-hour forwarding) and their process for urgent communications. Some FDA agent providers offer 24/7 availability and expedited handling for critical FDA communications. If your current agent is not responsive, you can change agents^[1], though this requires updating your FDA registration^[1].

References

21 CFR Part 807 — Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices (FDA) — 2020-01-01 — 21 CFR 807.40

Q7: Can I change my FDA U.S. Agent?

Yes, you can change your FDA U.S. Agent at any time by updating your establishment registration in the FDA's FURLS (FDA Unified Registration and Listing System). The process involves: logging into your FURLS account, updating the U.S. Agent information with the new agent's details (name, address, phone, email), and submitting the update. The change typically takes effect immediately in the FDA system. However, you should coordinate with both your old and new agents to ensure a smooth transition, especially if there are any pending FDA communications. Some manufacturers change agents due to service issues, cost, or strategic reasons. There's no limit on how often you can change agents, though frequent changes may be administratively burdensome.

Provider Comparison Table

Provider	Service Types	Languages	Response SLA
Registrar Corp	US	US Agent Services, FDA Registration/Listing Support	English, Spanish	24h
NSF (FDA US Agent Services)	US	US Agent Services, Regulatory Consulting	English	24h
EAS Consulting Group	US	US Agent Services, FDA Registration/Listing Support	English	24h
AlvaMed (FDA US Agent Representation)	US	US Agent Services, FDA Registration/Listing Support	English, Spanish	Custom
FDA Solutions Group, LLC	US	US Agent Services, FDA Registration/Listing Support	English, Spanish	24h
Willow Glen Consultancy LLC	US	US Agent Services, FDA Registration/Listing Support	English, Chinese	48h
MarketReady Insights	US	US Agent Services, FDA Registration/Listing Support	English	48h
FDAAgentPro Pro	US	US Agent Services, FDA Registration/Listing Support	English, Spanish	48h
DSI (US Agent Services)	US	US Agent Services, FDA Registration/Listing Support	English	24h
mdi Consultants	US	US Agent Services, FDA Registration/Listing Support	English	24h

Sources & Official Guidance

FDA — U.S. Agent requirements (medical devices)
21 CFR Part 807 (Establishment Registration & Listing) includes U.S. Agent obligations for foreign establishments.
FDA — Device Registration and Listing
Official FDA overview of registration/listing processes.

Last Updated: 2026-02-04

Reviewed by: Cruxi Regulatory Affairs Team

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Comprehensive Buyer's Guide

1. Who Needs an FDA U.S. Agent for Medical Devices?

References

Frequently Asked Questions

Q1: What does an FDA U.S. Agent do?

References

Q2: Is a U.S. Agent required for all foreign manufacturers?

References

Q3: What affects FDA U.S. Agent pricing?

Q4: What should I check before choosing a U.S. Agent?

References

Q5: Can a U.S. Agent also help with FDA registration steps?

Q6: What happens if my U.S. Agent doesn't forward FDA communications promptly?

References

Q7: Can I change my FDA U.S. Agent?

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Provider Comparison Table

Sources & Official Guidance